# C_2016024EN.01011901.xml

| 22.1.2016 | EN | Official Journal of the European Union | C 24/119 |
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22.1.2016

EN

Official Journal of the European Union

C 24/119

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P7_TA(2013)0039

Transparency of measures regulating the prices of medicinal products for human use ***I

European Parliament legislative resolution of 6 February 2013 on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems (COM(2012)0084 — C7-0056/2012 — 2012/0035(COD))

(Ordinary legislative procedure: first reading)

(2016/C 024/21)

The European Parliament,

The European Parliament

| — | having regard to the Commission proposal to Parliament and the Council (COM(2012)0084), |
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—

having regard to the Commission proposal to Parliament and the Council (COM(2012)0084),

| — | having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0056/2012), |
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—

having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0056/2012),

| — | having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis, |
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—

having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
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—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Austrian National Council and by the Luxembourg Chamber of Deputies, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
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—

having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Austrian National Council and by the Luxembourg Chamber of Deputies, asserting that the draft legislative act does not comply with the principle of subsidiarity,

| — | having regard to the opinion of the European Economic and Social Committee of 12 July 2012 (1), |
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—

having regard to the opinion of the European Economic and Social Committee of 12 July 2012 (1),

1

| — | having regard to Rules 55 and 37 of its Rules of Procedure, |
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—

having regard to Rules 55 and 37 of its Rules of Procedure,

| — | having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on the Internal Market and Consumer Protection (A7-0015/2013), |
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—

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on the Internal Market and Consumer Protection (A7-0015/2013),

| 1. | Adopts its position at first reading hereinafter set out; |
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1.

Adopts its position at first reading hereinafter set out;

| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text; |
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2.

Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
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3.

Instructs its President to forward its position to the Council, the Commission and the national parliaments.

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(1)  OJ C 299, 4.10.2012, p. 81.

1

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P7_TC1-COD(2012)0035

Position of the European Parliament adopted at first reading on 6 February 2013 with a view to the adoption of Directive 2013/.../EU of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

| (1) | Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (3) was adopted so as to remove distortions to intra-Community trade in medicinal products. |
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(1)

Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (3) was adopted so as to remove distortions to intra-Community trade in medicinal products.

| (2) | In order to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicinal products, substantive changes are necessary to all major provisions of Directive 89/105/EEC. Therefore, in the interest of clarity, Directive 89/105/EEC should be repealed and replaced by this Directive. |
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(2)

In order to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicinal products, substantive changes are necessary to all major provisions of Directive 89/105/EEC. Therefore, in the interest of clarity, Directive 89/105/EEC should be repealed and replaced by this Directive.

| (3) | Union legislation provides a harmonised framework for the authorisation of medicinal products for human use. According to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (4), medicinal products may be placed on the market in the Union only after they have received a marketing authorisation based on the evaluation of their quality, safety and efficacy. |
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(3)

Union legislation provides a harmonised framework for the authorisation of medicinal products for human use. According to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (4), medicinal products may be placed on the market in the Union only after they have received a marketing authorisation based on the evaluation of their quality, safety and efficacy.

| (4) | Member States have been confronted with a steady rise in pharmaceutical expenditure over the last decades, leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicines

  medicinal products
  in the framework of their public health insurance systems. In particular, Member State authorities have implemented a broad range of measures to control the prescription of medicines

  medicinal products
  , to regulate their prices or to establish the conditions of their public funding. Such measures mainly aim at promoting public health
  for all citizens
  by ensuring the availability of adequate supplies of
  effective
  medicinal products
  on equal terms to all citizens of the Union
  at reasonable costs, while ensuring the financial stability of public health insurance systems

  equal access to high-quality healthcare for all
  .
  Those measures should also aim to promote research and development of new medicinal products and to promote medical innovation. Medicines classed as essential on the WHO list should be available to patients in all Member States, irrespectively of the size of the market
  . [Am. 3] |
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(4)

Member States have been confronted with a steady rise in pharmaceutical expenditure over the last decades, leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicines

  medicinal products
  in the framework of their public health insurance systems. In particular, Member State authorities have implemented a broad range of measures to control the prescription of medicines

  medicinal products
  , to regulate their prices or to establish the conditions of their public funding. Such measures mainly aim at promoting public health
  for all citizens
  by ensuring the availability of adequate supplies of
  effective
  medicinal products
  on equal terms to all citizens of the Union
  at reasonable costs, while ensuring the financial stability of public health insurance systems

  equal access to high-quality healthcare for all
  .
  Those measures should also aim to promote research and development of new medicinal products and to promote medical innovation. Medicines classed as essential on the WHO list should be available to patients in all Member States, irrespectively of the size of the market
  . [Am. 3]

| (4a) | Ensuring patients’ access to medicinal products throughout the Union and effective free movement of goods requires that Member States make a reasonable use of external reference pricing, namely by reference to Member States with a comparable income level. The unconditional use of external reference pricing has been proven to reduce the availability of medicinal products by encouraging shortages in Member States with lower price levels. [Am. 4] |
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(4a)

Ensuring patients’ access to medicinal products throughout the Union and effective free movement of goods requires that Member States make a reasonable use of external reference pricing, namely by reference to Member States with a comparable income level. The unconditional use of external reference pricing has been proven to reduce the availability of medicinal products by encouraging shortages in Member States with lower price levels. [Am. 4]

| (5) | Disparities in national measures may hinder or distort intra-Union trade in medicinal products and distort competition, thereby directly affecting the functioning of the internal market in medicinal products. |
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(5)

Disparities in national measures may hinder or distort intra-Union trade in medicinal products and distort competition, thereby directly affecting the functioning of the internal market in medicinal products.

| (6) | In order to reduce the effects of the disparities on the internal market, national measures should comply with minimum procedural requirements enabling the parties concerned to verify that those measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto.
  Those minimum procedural requirements should also ensure legal certainty and transparency for the competent authorities when adopting decisions relating to the pricing and coverage of medicinal products by public health insurance systems, while promoting the production of medicinal products, accelerating the entry into the market of generic medicinal products and encouraging research and development of new medicinal products.
  However, those requirements should not affect the policies of those Member States which rely primarily upon free competition to determine the price of medicinal products. They also should not affect national policies on price setting and on the determination of social security schemes, except as far as it is necessary to attain transparency within the meaning of this Directive and to ensure the functioning of the internal market. [Am. 5] |
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(6)

In order to reduce the effects of the disparities on the internal market, national measures should comply with minimum procedural requirements enabling the parties concerned to verify that those measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto.
  Those minimum procedural requirements should also ensure legal certainty and transparency for the competent authorities when adopting decisions relating to the pricing and coverage of medicinal products by public health insurance systems, while promoting the production of medicinal products, accelerating the entry into the market of generic medicinal products and encouraging research and development of new medicinal products.
  However, those requirements should not affect the policies of those Member States which rely primarily upon free competition to determine the price of medicinal products. They also should not affect national policies on price setting and on the determination of social security schemes, except as far as it is necessary to attain transparency within the meaning of this Directive and to ensure the functioning of the internal market. [Am. 5]

| (7) | In order to ensure the effectiveness of the internal market in medicinal products, this Directive should apply to all medicinal products for human use within the meaning of Directive 2001/83/EC. |
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(7)

In order to ensure the effectiveness of the internal market in medicinal products, this Directive should apply to all medicinal products for human use within the meaning of Directive 2001/83/EC.

| (8) | Due to diversity of national measures managing the consumption of medicinal products, regulating their prices or establishing the conditions of their public funding it is necessary to clarify Directive 89/105/EEC. In particular this Directive should cover all types of measures devised by Member States and susceptible to impact the internal market. Since the adoption of Directive 89/105/EEC, the pricing and reimbursement procedures have evolved and have become more complex. While some Member States have interpreted the scope of Directive 89/105/EEC restrictively, the Court of Justice ruled that those pricing and reimbursement procedures fall within the scope of Directive 89/105/EEC given the objectives of that Directive and the need to ensure its effectiveness. Therefore, this Directive should reflect the developments in national pricing and reimbursement policies. Given that specific rules and procedures exist in the area of public procurement and voluntary contractual agreements, national measures involving public procurement and voluntary contractual agreements should be excluded from the scope of this Directive. |
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(8)

Due to diversity of national measures managing the consumption of medicinal products, regulating their prices or establishing the conditions of their public funding it is necessary to clarify Directive 89/105/EEC. In particular this Directive should cover all types of measures devised by Member States and susceptible to impact the internal market. Since the adoption of Directive 89/105/EEC, the pricing and reimbursement procedures have evolved and have become more complex. While some Member States have interpreted the scope of Directive 89/105/EEC restrictively, the Court of Justice ruled that those pricing and reimbursement procedures fall within the scope of Directive 89/105/EEC given the objectives of that Directive and the need to ensure its effectiveness. Therefore, this Directive should reflect the developments in national pricing and reimbursement policies. Given that specific rules and procedures exist in the area of public procurement and voluntary contractual agreements, national measures involving public procurement and voluntary contractual agreements should be excluded from the scope of this Directive.

| (8a) | Competent authorities and marketing authorisation holders increasingly engage in contractual agreements to provide patients with access to innovative treatments by including a medicinal product in the scope of public health insurance systems whilst monitoring elements agreed upfront and for a defined period of time in order, in particular, to address evidentiary uncertainties relating to the effectiveness and/or relative efficacy or the appropriate use of a specific medicinal product. The delay in defining the terms and conditions of such contractual agreements often exceeds the time limits set and justifies the exclusion of such agreements from the scope of this Directive. Those agreements should be limited to therapeutic areas where their conclusion would effectively facilitate or enable patients' access to innovative medicinal products, would remain voluntary and would not affect the right of the marketing authorisation holder to submit an application in compliance with this Directive. [Am. 6] |
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(8a)

Competent authorities and marketing authorisation holders increasingly engage in contractual agreements to provide patients with access to innovative treatments by including a medicinal product in the scope of public health insurance systems whilst monitoring elements agreed upfront and for a defined period of time in order, in particular, to address evidentiary uncertainties relating to the effectiveness and/or relative efficacy or the appropriate use of a specific medicinal product. The delay in defining the terms and conditions of such contractual agreements often exceeds the time limits set and justifies the exclusion of such agreements from the scope of this Directive. Those agreements should be limited to therapeutic areas where their conclusion would effectively facilitate or enable patients' access to innovative medicinal products, would remain voluntary and would not affect the right of the marketing authorisation holder to submit an application in compliance with this Directive. [Am. 6]

| (9) | Any measure to regulate, either directly or indirectly, the prices of medicinal products, as well as any measure
  , including recommendations that may be required,
  to determine their coverage by public health insurance systems should be based on
  transparent,
  objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies, including judicial remedies

  , in accordance with national procedures
  , to affected companies. These requirements should equally apply to national, regional or local measures to control or promote the prescription of specific medicinal products as such measures also determine their effective coverage by public health insurance systems. [Am. 7] |
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(9)

Any measure to regulate, either directly or indirectly, the prices of medicinal products, as well as any measure
  , including recommendations that may be required,
  to determine their coverage by public health insurance systems should be based on
  transparent,
  objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies, including judicial remedies

  , in accordance with national procedures
  , to affected companies. These requirements should equally apply to national, regional or local measures to control or promote the prescription of specific medicinal products as such measures also determine their effective coverage by public health insurance systems. [Am. 7]

| (9a) | The criteria underlying any decision directly or indirectly regulating the prices of medicinal products, as well as any measure determining the extent to which they shall be covered by public health insurance systems should include the assessment of unmet medical needs, clinical and societal benefits and innovation, as laid down in the opinion of the European Economic and Social Committee of 12 July 2012 on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems

   (5)

  . Such criteria should also include the protection of the most vulnerable groups of the population. [Am. 8] |
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(9a)

The criteria underlying any decision directly or indirectly regulating the prices of medicinal products, as well as any measure determining the extent to which they shall be covered by public health insurance systems should include the assessment of unmet medical needs, clinical and societal benefits and innovation, as laid down in the opinion of the European Economic and Social Committee of 12 July 2012 on the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems

   (5)

  . Such criteria should also include the protection of the most vulnerable groups of the population. [Am. 8]

| (10) | Applications to approve the price of a medicinal product or to determine its coverage by the public health insurance system should not delay the placing on the market of that product beyond what is necessary. It is therefore desirable that this Directive sets out mandatory time limits within which national decisions should be made. In order to be effective, the prescribed time periods should run from the receipt of an application until the entry into force of the corresponding decision. They should include all
  recommendations and
  expert evaluations, including health technology assessments where applicable, and all administrative steps required for the decision to be adopted and take legal effect. [Am. 9] |
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(10)

Applications to approve the price of a medicinal product or to determine its coverage by the public health insurance system should not delay the placing on the market of that product beyond what is necessary. It is therefore desirable that this Directive sets out mandatory time limits within which national decisions should be made. In order to be effective, the prescribed time periods should run from the receipt of an application until the entry into force of the corresponding decision. They should include all
  recommendations and
  expert evaluations, including health technology assessments where applicable, and all administrative steps required for the decision to be adopted and take legal effect. [Am. 9]

| (10a) | In order to facilitate compliance with those time limits, it may be useful for applicants to start procedures for price approval or for inclusion of a medicinal product in the public health insurance systems already before the marketing authorisation is formally granted. To this end, Member States may allow applicants to submit an application as soon as a positive opinion on the granting of the marketing authorisation for the medicinal product concerned has been issued by the Committee for Medicinal Products for Human Use or by the national competent authority in charge of the marketing authorisation procedure, as appropriate. In such cases the time limits should run from the formal receipt of the marketing authorisation. [Am. 10] |
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(10a)

In order to facilitate compliance with those time limits, it may be useful for applicants to start procedures for price approval or for inclusion of a medicinal product in the public health insurance systems already before the marketing authorisation is formally granted. To this end, Member States may allow applicants to submit an application as soon as a positive opinion on the granting of the marketing authorisation for the medicinal product concerned has been issued by the Committee for Medicinal Products for Human Use or by the national competent authority in charge of the marketing authorisation procedure, as appropriate. In such cases the time limits should run from the formal receipt of the marketing authorisation. [Am. 10]

| (10b) | The Union's support for cooperation on health technology assessment in accordance with Article 15 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare

   (6)

  aims to optimise and coordinate health technology assessment methodologies which should ultimately also reduce delays in pricing and reimbursement processes of medicinal products for which Member States use health technology assessment as part of their decision-making process. Health technology assessment includes, in particular, information on the relative efficacy as well as on the short- and long-term effectiveness, where appropriate, of health technologies, also taking into account broader economic and social benefits or cost-effectiveness of the assessed medicinal product, in accordance with the methodology of the competent authorities. Health technology assessment is a multidisciplinary process that summarises information about the medical, social, economic and ethical aspects relating to the use of health technology in a systematic, transparent, unbiased and robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient-focused and that seek to achieve best value. [Am. 11] |
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(10b)

The Union's support for cooperation on health technology assessment in accordance with Article 15 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare

   (6)

  aims to optimise and coordinate health technology assessment methodologies which should ultimately also reduce delays in pricing and reimbursement processes of medicinal products for which Member States use health technology assessment as part of their decision-making process. Health technology assessment includes, in particular, information on the relative efficacy as well as on the short- and long-term effectiveness, where appropriate, of health technologies, also taking into account broader economic and social benefits or cost-effectiveness of the assessed medicinal product, in accordance with the methodology of the competent authorities. Health technology assessment is a multidisciplinary process that summarises information about the medical, social, economic and ethical aspects relating to the use of health technology in a systematic, transparent, unbiased and robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient-focused and that seek to achieve best value. [Am. 11]

| (11) | The time limits for the inclusion of medicinal products in the public health insurance systems set out in Directive 89/105/EEC are mandatory as clarified by the case-law of the Court of Justice. Experience has shown that those time limits are not always respected and that there is need to ensure legal certainty and improve the procedural rules related to the inclusion of medicinal products in the scope of public health insurance systems. Therefore, an effective and rapid remedies procedure should be put in place. |
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(11)

The time limits for the inclusion of medicinal products in the public health insurance systems set out in Directive 89/105/EEC are mandatory as clarified by the case-law of the Court of Justice. Experience has shown that those time limits are not always respected and that there is need to ensure legal certainty and improve the procedural rules related to the inclusion of medicinal products in the scope of public health insurance systems. Therefore, an effective and rapid remedies procedure should be put in place.

| (12) | In its Communication of 8 July 2009 entitled ‘Executive Summary of the Pharmaceutical Sector Inquiry Report’ the Commission demonstrated that pricing and reimbursement procedures often unnecessarily delay the launch of generic medicines

  or biosimilar medicinal products
  in Union markets. Approving the price of generic
  or biosimilar
  medicinal products and their coverage by the public health insurance system should not require any new or detailed assessment when the reference product has already been priced and included in the public health insurance system. It is therefore appropriate to lay down shorter time limits for generic
  or biosimilar
  medicinal products in those cases. [Am. 12] |
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(12)

In its Communication of 8 July 2009 entitled ‘Executive Summary of the Pharmaceutical Sector Inquiry Report’ the Commission demonstrated that pricing and reimbursement procedures often unnecessarily delay the launch of generic medicines

  or biosimilar medicinal products
  in Union markets. Approving the price of generic
  or biosimilar
  medicinal products and their coverage by the public health insurance system should not require any new or detailed assessment when the reference product has already been priced and included in the public health insurance system. It is therefore appropriate to lay down shorter time limits for generic
  or biosimilar
  medicinal products in those cases. [Am. 12]

| (13) | The judicial remedies available in the Member States have played a limited role in ensuring compliance with the time limits due to the often lengthy procedures in national jurisdictions, which deter affected companies from initiating legal action. Therefore, effective mechanisms are necessary to
  ensure swift infringement resolution by means of administrative mediation in advance of judicial proceedings, as well as to
  control and enforce compliance with the time limits for pricing and reimbursement decisions.
  To this end, Member States might designate an administrative body, which may be an existing one. [Am. 13] |
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(13)

The judicial remedies available in the Member States have played a limited role in ensuring compliance with the time limits due to the often lengthy procedures in national jurisdictions, which deter affected companies from initiating legal action. Therefore, effective mechanisms are necessary to
  ensure swift infringement resolution by means of administrative mediation in advance of judicial proceedings, as well as to
  control and enforce compliance with the time limits for pricing and reimbursement decisions.
  To this end, Member States might designate an administrative body, which may be an existing one. [Am. 13]

| (14) | The quality, safety and efficacy of medicinal products, including the bioequivalence of generic
  or the biosimilarity of biosimilar
  medicinal products with the reference product, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, Member States

  decisions
  ,
  the competent authorities responsible for those decisions
  should therefore not re-assess the
  essential
  elements on which the marketing authorisation is based, including the quality, safety, efficacy or, bioequivalence
  or biosimilarity
  of the medicinal product.
  Similarly, in the case of orphan drugs, the competent authorities should not re-assess the criteria of the orphan designation. However, competent authorities should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product as well as the possibility of including or generating additional relevant data for the purpose of assessing a medicinal product in the context of its inclusion in the scope of the public health insurance system. [Am. 14] |
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(14)

The quality, safety and efficacy of medicinal products, including the bioequivalence of generic
  or the biosimilarity of biosimilar
  medicinal products with the reference product, are ascertained in the framework of marketing authorisation procedures. In the framework of pricing and reimbursement procedures, Member States

  decisions
  ,
  the competent authorities responsible for those decisions
  should therefore not re-assess the
  essential
  elements on which the marketing authorisation is based, including the quality, safety, efficacy or, bioequivalence
  or biosimilarity
  of the medicinal product.
  Similarly, in the case of orphan drugs, the competent authorities should not re-assess the criteria of the orphan designation. However, competent authorities should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product as well as the possibility of including or generating additional relevant data for the purpose of assessing a medicinal product in the context of its inclusion in the scope of the public health insurance system. [Am. 14]

| (14a) | The non re-assessment of the elements on which the marketing authorisation is based within the framework of pricing and reimbursement procedures should not, however, prevent the competent authorities from requesting, accessing and using data generated during the marketing authorisation process for the purpose of evaluation and health technology assessment. Data sharing between the competent authorities responsible for marketing authorisation and for pricing and reimbursement should be possible at national level if such sharing exists. The competent authorities should also be able to include or generate additional relevant data for the purposes of evaluation and health technology assessment. [Am. 15] |
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(14a)

The non re-assessment of the elements on which the marketing authorisation is based within the framework of pricing and reimbursement procedures should not, however, prevent the competent authorities from requesting, accessing and using data generated during the marketing authorisation process for the purpose of evaluation and health technology assessment. Data sharing between the competent authorities responsible for marketing authorisation and for pricing and reimbursement should be possible at national level if such sharing exists. The competent authorities should also be able to include or generate additional relevant data for the purposes of evaluation and health technology assessment. [Am. 15]

| (15) | In accordance with Directive 2001/83/EC, intellectual property rights do not provide a valid ground to refuse, suspend or revoke a marketing authorisation. By the same token, applications, decision-making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by public health insurance systems should be considered administrative procedures which, as such, are independent from the enforcement of intellectual property rights. The national authorities in charge of those procedures, when examining an application with respect to a
  bioequivalent
  generic
  or biosimilar
  medicinal product, should not request information concerning the patent status of the reference medicinal product and

  , but they
  should not

  be allowed to
  examine the validity of an alleged violation of intellectual property rights should the generic
  or biosimilar
  medicinal product be manufactured or placed on the market subsequently to their decision. Consequently,

  That competence should remain with Member States. Without prejudice to the responsibility of Member States to examine information,
  intellectual property issues should neither interfere with nor delay pricing and
  procedures for
  reimbursement procedures

  of generic medicines
  in the Member States. [Am. 16] |
| --- | --- |

(15)

In accordance with Directive 2001/83/EC, intellectual property rights do not provide a valid ground to refuse, suspend or revoke a marketing authorisation. By the same token, applications, decision-making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by public health insurance systems should be considered administrative procedures which, as such, are independent from the enforcement of intellectual property rights. The national authorities in charge of those procedures, when examining an application with respect to a
  bioequivalent
  generic
  or biosimilar
  medicinal product, should not request information concerning the patent status of the reference medicinal product and

  , but they
  should not

  be allowed to
  examine the validity of an alleged violation of intellectual property rights should the generic
  or biosimilar
  medicinal product be manufactured or placed on the market subsequently to their decision. Consequently,

  That competence should remain with Member States. Without prejudice to the responsibility of Member States to examine information,
  intellectual property issues should neither interfere with nor delay pricing and
  procedures for
  reimbursement procedures

  of generic medicines
  in the Member States. [Am. 16]

| (15a) | Member States should ensure the public availability of documents and information in an appropriate publication, in accordance with national practice, which could include electronic and online format. They should also ensure that the information delivered is understandable and supplied in a reasonable quantity. The Commission and the Member States should also examine how to continue to co-operate on the functioning of the EURIPID price information database, which provides Union-wide added value in terms of price transparency. [Am. 17] |
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(15a)

Member States should ensure the public availability of documents and information in an appropriate publication, in accordance with national practice, which could include electronic and online format. They should also ensure that the information delivered is understandable and supplied in a reasonable quantity. The Commission and the Member States should also examine how to continue to co-operate on the functioning of the EURIPID price information database, which provides Union-wide added value in terms of price transparency. [Am. 17]

| (15b) | The principle of transparency, integrity and independence of the decision-making process within the national competent authorities should be ensured by the public disclosure of the names of experts participating in the bodies responsible for pricing and reimbursement decisions, together with their declarations of interest and the procedural steps leading to pricing and reimbursement decisions. [Am. 18] |
| --- | --- |

(15b)

The principle of transparency, integrity and independence of the decision-making process within the national competent authorities should be ensured by the public disclosure of the names of experts participating in the bodies responsible for pricing and reimbursement decisions, together with their declarations of interest and the procedural steps leading to pricing and reimbursement decisions. [Am. 18]

| (16) | Member States have frequently amended their health insurance schemes or adopted new measures falling within the scope of Directive 89/105/EEC. It is therefore necessary to establish
  an
  information mechanisms

  mechanism
  intended, on the one hand, to ensure the consultation of
  all
  interested stakeholders and, on the other hand, to facilitate preventive dialogue with the Commission as regards the application of this Directive

  including civil society organisations
  . [Am. 19] |
| --- | --- |

(16)

Member States have frequently amended their health insurance schemes or adopted new measures falling within the scope of Directive 89/105/EEC. It is therefore necessary to establish
  an
  information mechanisms

  mechanism
  intended, on the one hand, to ensure the consultation of
  all
  interested stakeholders and, on the other hand, to facilitate preventive dialogue with the Commission as regards the application of this Directive

  including civil society organisations
  . [Am. 19]

| (17) | Since the objective of this Directive, namely providing minimal transparency rules to ensure the functioning of the internal market, cannot be sufficiently achieved by the Member States, as the notion of transparency of national measures is understood and applied differently in each Member State, and can therefore, by reason of the scale of the action be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. |
| --- | --- |

(17)

Since the objective of this Directive, namely providing minimal transparency rules to ensure the functioning of the internal market, cannot be sufficiently achieved by the Member States, as the notion of transparency of national measures is understood and applied differently in each Member State, and can therefore, by reason of the scale of the action be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

| (18) | In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (7), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified, |
| --- | --- |

(18)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (7), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified,

HAVE ADOPTED THIS DIRECTIVE:

Chapter I

Scope and definitions

Article 1

Subject matter and scope

1.   Member States shall ensure that any national, regional or local measure, whether laid down by law, regulation or administrative action, to control the prices of medicinal products for human use or to determine the range of medicinal products covered by public health insurance systems, including the extent and conditions of their coverage, complies with the requirements of this Directive.
  Member States shall ensure that those measures are not duplicated at regional or local level in their respective territories. [Am. 20]

2.   This Directive shall not apply to the following:

| (a) | voluntary contractual agreements concluded
  voluntarily
  between public authorities and the marketing authorisation holder for a medicinal product
  , that have as their object to enable

  include a medicinal product under the scope of a public health insurance system while monitoring elements agreed upfront among both parties relating to the effectiveness and/or relative efficacy or the appropriate use of the given medicinal product, and with a view to enabling
  the effective provision of this

  that
  medicine to patients under specific conditions
  and during an agreed period of time
  ; [Am. 21] |
| --- | --- |

(a)

voluntary contractual agreements concluded
  voluntarily
  between public authorities and the marketing authorisation holder for a medicinal product
  , that have as their object to enable

  include a medicinal product under the scope of a public health insurance system while monitoring elements agreed upfront among both parties relating to the effectiveness and/or relative efficacy or the appropriate use of the given medicinal product, and with a view to enabling
  the effective provision of this

  that
  medicine to patients under specific conditions
  and during an agreed period of time
  ; [Am. 21]

| (b) | national measures intended to determine the prices or the coverage of medicinal products by public health insurance systems which are subject to national or Union legislation on public procurement, in particular Council Directive 89/665/EEC (8), Council Directive 92/13/EEC (9) and Directive 2004/18/EC of the European Parliament and of the Council (10). |
| --- | --- |

(b)

national measures intended to determine the prices or the coverage of medicinal products by public health insurance systems which are subject to national or Union legislation on public procurement, in particular Council Directive 89/665/EEC (8), Council Directive 92/13/EEC (9) and Directive 2004/18/EC of the European Parliament and of the Council (10).

This Directive shall apply to measures intended to determine which medicinal products may be included in contractual agreements or public procurement procedures.
  In accordance with Union and national law regarding business confidentiality, basic information regarding medicinal products included in contractual agreements or public procurement procedures, such as the name of the product and the name of the marketing authorisation holder, shall be made publicly available once agreements or procedures are concluded. [Am. 22]

3.   Nothing in this Directive shall permit the placing on the market of a medicinal product which has not received marketing authorisation as provided for in Article 6 of Directive 2001/83/EC.

3a.
     
  This Directive may not call into question a marketing authorisation relating to a medicinal product granted in accordance with the procedure referred to in Article 6 of Directive 2001/83/EC. [Am. 23]

Article 2

Definitions

For the purposes of this Directive, the following definitions apply:

| (1) | ‘medicinal product’ means a medicinal product as defined in Article 1 of Directive 2001/83/EC; |
| --- | --- |

(1)

‘medicinal product’ means a medicinal product as defined in Article 1 of Directive 2001/83/EC;

| (2) | ‘reference medicinal product’ means a reference medicinal product as defined in point (a) of Article 10(2) of Directive 2001/83/EC; |
| --- | --- |

(2)

‘reference medicinal product’ means a reference medicinal product as defined in point (a) of Article 10(2) of Directive 2001/83/EC;

| (3) | ‘generic medicinal product’ means a generic medicinal product as defined in point (b) of Article 10(2) of Directive 2001/83/EC; |
| --- | --- |

(3)

‘generic medicinal product’ means a generic medicinal product as defined in point (b) of Article 10(2) of Directive 2001/83/EC;

| (3a) | ‘biosimilar medicinal product’ means a similar biological medicinal product approved in accordance with Article 10(4) of Directive 2001/83/EC; [Am. 24] |
| --- | --- |

(3a)

‘biosimilar medicinal product’ means a similar biological medicinal product approved in accordance with Article 10(4) of Directive 2001/83/EC; [Am. 24]

| (4) | ‘health technology’ means a health technology as defined in point (l) of Article 3 of Directive 2011/24/EU; |
| --- | --- |

(4)

‘health technology’ means a health technology as defined in point (l) of Article 3 of Directive 2011/24/EU;

| (5) | ‘health technology assessment’ means an assessment of

  which as a minimum includes
  the relative efficacy or of the short- and long-term effectiveness of the medicinal product compared to other health technologies
  or interventions
  in use for treating the associated condition; [Am. 25] |
| --- | --- |

(5)

‘health technology assessment’ means an assessment of

  which as a minimum includes
  the relative efficacy or of the short- and long-term effectiveness of the medicinal product compared to other health technologies
  or interventions
  in use for treating the associated condition; [Am. 25]

| (5a) | ‘voluntary contractual agreement’ means an agreement concluded between public authorities and the marketing authorisation holder for a medicinal product, which is neither mandatory nor required by law, nor the only alternative to being included in the national pricing and reimbursement scheme; [Am. 26] |
| --- | --- |

(5a)

‘voluntary contractual agreement’ means an agreement concluded between public authorities and the marketing authorisation holder for a medicinal product, which is neither mandatory nor required by law, nor the only alternative to being included in the national pricing and reimbursement scheme; [Am. 26]

| (5b) | ‘vulnerable groups’ means those groups of the population most sensitive to measures determining the extent to which medicinal products are covered by public health insurance systems, such as children, pensioners, the unemployed, those reliant on orphan drugs and the chronically ill. [Am. 27] |
| --- | --- |

(5b)

‘vulnerable groups’ means those groups of the population most sensitive to measures determining the extent to which medicinal products are covered by public health insurance systems, such as children, pensioners, the unemployed, those reliant on orphan drugs and the chronically ill. [Am. 27]

Chapter II

Pricing of medicinal products

Article 3

Price approval

1.   Paragraphs 2 to 9 shall apply if the marketing of a medicinal product is permitted only after the competent authorities of the Member State concerned have approved the price of the product.

2.   Member States shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time

  once the marketing authorisation of the product has been granted. Member States may also provide the possibility for the applicant of a marketing authorisation to submit such a price approval application once the Committee for Medicinal Products for Human Use established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

   (11)

  or the national competent authority has issued a positive opinion on the granting of a marketing authorisation for the medicinal product concerned
  . The competent authorities shall provide the applicant with an official acknowledgement of receipt
  within 10 days of receipt of the application
  . [Am. 28]

3.   Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days

  90 days
  of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the marketing authorisation holder. However, with respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days

  30 days
  , provided that the price of the reference medicinal product has been approved by the competent authorities.
  Where appropriate, Member States shall use health technology assessment as part of their decision-making process on the pricing of medicinal products. [Am. 29]

4.   Member States shall establish in detail the particulars and documents to be submitted by the applicant.

5.   If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days

  90 days
  of receipt of this additional information. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be in all events 15 days

  30 days
  , provided that the price of the reference medicinal product has been approved by the competent authorities. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
  [Am. 30]

6.   In the absence of a decision within the relevant time limit set out in paragraphs 3 and 5, the applicant shall be entitled to market the product at the price proposed.

7.   If the competent authorities decide not to permit the marketing of the medicinal product concerned at the price proposed by the applicant, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.

8.   Member States shall publish in an appropriate publication and communicate to the Commission the criteria which the competent authorities must take into account when approving the prices of medicinal products.
  Those criteria and information about the decision-making bodies at national or regional level shall be made publicly available. [Am. 31]

9.   If the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative, the decision shall contain a statement of reasons based on objective and verifiable criteria, including any evaluation, expert opinion or recommendation on which it is based. The decision shall be communicated to the marketing authorisation holder, who shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.
  The decision and summary of the statement of reasons shall be made publicly available without delay. [Am. 32]

Article 4

Price increase

1.   Without prejudice to Article 5, paragraphs (2) to (6) shall apply if an increase in the price of a medicinal product is permitted only after prior approval has been obtained from the competent authorities.

2.   Member States shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time

  in accordance with national law
  . The competent authorities shall provide the applicant with an official acknowledgement of receipt
  within 10 days of receipt of the application
  . [Am. 33]

3.   Member States shall ensure that a decision on

  to approve or reject
  an application submitted, in accordance with the requirements laid down in the Member State concerned, by a marketing authorisation holder to increase the price of a medicinal product, is adopted and communicated to the applicant within 60 days

  90 days
  of its receipt. [Am. 34]

In case of an exceptional number of applications, the time limit set out in the first subparagraph may be extended once only for a further 60 days. The applicant shall be notified of such an extension before the expiry of the time limit set out in the first subparagraph.

4.   Member States shall establish in detail the particulars and documents to be submitted by the applicant.

The applicant shall furnish the competent authorities with adequate information, including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days

  90 days
  of receipt of this additional information. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
  [Am. 35]

5.   In the absence of a decision within the relevant time limit referred to in paragraphs 3 and 4, the applicant shall be entitled to apply the price increase requested.
  [Am. 36]

6.   If the competent authorities decide not to permit the whole or part of the price increase requested, the decision shall contain a statement of reasons based on objective and verifiable criteria and the applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.

Article 5

Price freeze and price reduction

1.   In the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall publish a statement of reasons for its decision based on objective and verifiable criteria, including, if applicable, a justification of the categories of products subject to the price freeze or price reduction.
  Member States shall carry out an annual review of such decisions of their competent authorities. [Am. 37]

2.   Marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons. The application shall contain an adequate statement of reasons. Member States shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time. The competent authorities shall provide the applicant with an official acknowledgement of receipt
  within 10 days of receipt of the application
  . [Am. 38]

3.   Member States shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days

  90 days
  of the receipt of the application. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days

  90 days
  of receipt of this additional information. If the derogation is granted, the competent authorities shall forthwith publish an announcement of the price increase allowed. [Am. 39]

If there is an exceptional number of applications, the relevant time limit set out in the first subparagraph may be extended once only for a further 60 days. The applicant shall be notified of such extension before the expiry of the time limit set out in the first subparagraph.

Article 6

Controls on profits

Where a Member State adopts a system of direct or indirect controls on the profitability of persons responsible for placing medicinal products on the market, the Member State concerned shall publish the following information in an appropriate publication and communicate it to the Commission:

| (a) | the method or methods used in the Member State concerned to define profitability: return on sales and/or return on capital; |
| --- | --- |

(a)

the method or methods used in the Member State concerned to define profitability: return on sales and/or return on capital;

| (b) | the range of target profit currently permitted to persons responsible for placing medicinal products on the market in the Member State concerned; |
| --- | --- |

(b)

the range of target profit currently permitted to persons responsible for placing medicinal products on the market in the Member State concerned;

| (c) | the criteria according to which target rates of profit are accorded to an individual responsible for placing medicinal products on the market, together with the criteria according to which they will be allowed to retain profits above their targets in the Member State concerned; |
| --- | --- |

(c)

the criteria according to which target rates of profit are accorded to an individual responsible for placing medicinal products on the market, together with the criteria according to which they will be allowed to retain profits above their targets in the Member State concerned;

| (d) | the maximum percentage profit which any person responsible for placing medicinal products on the market is allowed to retain above his target in the Member State concerned. |
| --- | --- |

(d)

the maximum percentage profit which any person responsible for placing medicinal products on the market is allowed to retain above his target in the Member State concerned.

The information referred to in the first subparagraph shall be updated once a year or when significant changes are made.

Where, in addition to operating a system of direct or indirect controls on profits, a Member State operates a system of controls on the prices of certain types of medicinal products which are excluded from the scope of the profit control scheme, Articles 3, 4 and 5 shall, where relevant, apply to such price controls. However, those Articles shall not apply where the normal operation of a system of direct or indirect controls on profits results exceptionally in a price being fixed for an individual medicinal product.

Chapter III

Coverage of medicinal products by public health insurance systems

Article 7

Inclusion of medicinal products in public health insurance systems

1.   Paragraphs 2 to 8 shall apply if a medicinal product is covered by the public health insurance system only after the competent authorities have decided to include the medicinal product concerned in the scope of that system.

2.   Member States shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time. If the public health insurance system comprises several schemes or categories of coverage, the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice

  once the marketing authorisation of the product has been granted. Member States may also provide the possibility for the applicant of a marketing authorisation to submit such an inclusion application once the Committee for Medicinal Products for Human Use established by Regulation (EC) No 726/2004 or the national competent authority has issued a positive opinion on the granting of the marketing authorisation for the medicinal product concerned
  . The competent authorities shall provide the applicant with an official acknowledgement of receipt
  within 10 days of receipt of the application
  . [Am. 40]

3.   Member States shall establish in detail the particulars and documents to be submitted by the applicant.

4.   Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 60 days

  90 days
  of its receipt. However, with respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days

  30 days
  , provided that the reference medicinal product has already been included in the public health insurance system.
  Where appropriate, Member States shall use health technology assessment as part of their decision-making process on the inclusion of medicinal products in the scope of the public health insurance system. [Am. 41]

5.   If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days

  90 days
  of receipt of this additional information. However, with respect to medicinal products for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 15 days

  30 days
  , provided that the reference medicinal product has already been included in the public health insurance system. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
  [Am. 42]

6.   Irrespective of the organisation of their internal procedures, Member States shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this Article and the price approval procedure set out in Article 3 does not exceed 120 days

  180 days
  . However, with respect to the medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 30 days

  60 days
  , provided that the reference medicinal product has already been included in the public health insurance system. Those time limits may be extended in accordance with paragraph 5 of this Article or Article 3(5). [Am. 43]

7.   Any decision not to include a medicinal product within the scope of the public health insurance system shall contain a statement of reasons based upon objective and verifiable criteria. Any decision to include a medicinal product within the scope of the public health insurance system shall contain a statement of reasons justifying the decision, including the extent and conditions of the product’s coverage, on the basis of objective and verifiable criteria.

The decisions referred to in the first subparagraph shall also include any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all
  mediation and
  remedies
  procedures
  available, including judicial remedies, and the remedies procedure set out Article 8,

  and
  of the time limits for applying for such remedies

  applicable to those procedures
  .

The criteria governing the decisions referred to in the first subparagraph shall include assessments of unmet medical needs and of the clinical and societal benefits, innovation and the protection of the most vulnerable groups of the population. [Am. 44]

8.   Member States shall publish in an appropriate publication and communicate to the Commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system.
  Those criteria and information about the decision-making bodies at national or regional level shall be made publicly available. [Am. 45]

Article 8

Mediation and remedies

  procedure in case of non-compliance with the time limits related to the inclusion of medicinal products in health insurance systems

  procedures

1.   Member States shall ensure that effective and rapid
  mediation or
  remedies
  procedures
  are available to the applicant in case of
  unjustified delays or
  non-compliance with the time limits set in Article 7,
  and in accordance with their national law
  .

2.   For the purposes of the
  mediation or
  remedies procedure

  procedures
  Member States shall

  may
  designate a

  an administrative
  body and entrust it with the powers to:

| (a) | take, at the earliest opportunity and by way of interlocutory procedures, interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned;. |
| --- | --- |

(a)

take, at the earliest opportunity and by way of interlocutory procedures, interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned;.

| (b) | award damages to the applicant in case of non-compliance with time limits set in Article 7 where damages are claimed, unless the competent authority may prove that the delay is not imputable to it; |
| --- | --- |

(b)

award damages to the applicant in case of non-compliance with time limits set in Article 7 where damages are claimed, unless the competent authority may prove that the delay is not imputable to it;

| (c) | impose a penalty payment, calculated by day of delay. |
| --- | --- |

(c)

impose a penalty payment, calculated by day of delay.

For the purposes of point (c), the penalty payment shall be calculated depending on the seriousness of the infringement, its duration, the need to ensure that the penalty itself is a deterrent to further infringements.

Member States may provide that the body referred to in the first subparagraph may take into account the probable consequences of potential measures taken under the present paragraph for all interests likely to be harmed, as well as the public interest, and may decide not to take such measures when their negative consequences could exceed their benefits.

3.   A decision not to grant interim measure shall not prejudice any other claim of the applicant seeking such measures.

4.   Member States shall ensure that decisions taken by bodies responsible for remedies procedures can be effectively enforced.

5.   The body referred to in paragraph 2 shall be independent of the competent authorities in charge of controlling the prices of medicinal products for human use or in charge of determining the range of medicinal products covered by health insurance systems.

6.   The body referred to in paragraph 2 shall state reasons for its decision. Furthermore, where that body is not judicial in character, provision must be made to guarantee procedures whereby any allegedly illegal measure taken by the independent body or any alleged defect in the exercise of powers conferred on it can be subject to judicial review or review by another body which is a court or tribunal within the meaning of Article 267 of the Treaty on the Functioning of the European Union and independent of both the competent authority and the body referred to in paragraph 2.

The members of the body referred to in paragraph 2 shall be appointed and leave office under the same conditions as members of the judiciary as regards the authority responsible for their appointment, their period of office, and their removal. At least the president of that body shall have the same legal and professional qualifications as members of the judiciary. That body shall take its decisions following a procedure in which both sides are heard, and these decisions shall, by means determined by each Member State, be legally binding.
  [Am. 46]

Article 9

Exclusion of medicinal products from public health insurance systems

1.   Any decision to exclude a medicinal product from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the product concerned, shall contain a statement of reasons based on objective and verifiable criteria. Such decisions shall include
  assessments of unmet medical needs, the clinical impact and social costs, the protection of the most vulnerable groups of the population and
  any evaluation, expert opinion or recommendation on which they are based. The applicant shall be informed of all remedies available, including judicial remedies, and of the time limits for applying for such remedies. [Am. 47]

2.   Any decision to exclude a category of medicinal products from the scope of the public health insurance system, or to modify the extent or the conditions of coverage of the category concerned, shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication. [Am. 48]

2a.
     
  Any decision to exclude a medicinal product or a category of medicinal products from the scope of the public health insurance system shall be made publicly available, together with a summary of the statement of reasons. [Am. 49]

Article 10

Classification of medicinal products in view of their inclusion in public health insurance systems

1.   Paragraphs 2, 3 and 4 shall apply where medicinal products are grouped or classified according to therapeutic or other criteria for the purpose of their inclusion within the scope of the public health insurance system.

2.   Member States shall publish in an appropriate publication and communicate to the Commission the objective and verifiable criteria according to which medicinal products are classified in view of their inclusion in the public health insurance system.

3.   For the medicinal products subject to such grouping or classification, Member States shall publish in an appropriate publication and communicate to the Commission the methodologies used to determine the extent or conditions of their inclusion in the public health insurance system.

4.   At the request of the marketing authorisation holder, the competent authorities shall specify the objective data on the basis of which they have determined the arrangements of coverage for their medicinal product, in application of the criteria and methodologies referred to in paragraphs 2 and 3. In such a case, the competent authorities shall also inform the marketing authorisation holder of all remedies available, including judicial remedies, and of the time limits for applying for such remedies.

Article 11

Measures to control or promote the prescription of specific medicinal products

1.   Paragraphs 2, 3 and 4 shall apply where a Member State adopts measures intended to control or promote the prescription of specific named medicinal products
  or of a category of medicinal products
  . [Am. 50]

2.   Measures referred to in paragraph 1 shall be based on objective and verifiable criteria.

3.   Measures referred to in paragraph 1, including any evaluation, expert opinion or recommendation on which they are based, shall be published in an appropriate publication
  and made available to the public
  . [Am. 51]

4.   At the request of the marketing authorisation holder whose interests or legal position are affected by the measures referred to in paragraph 1, the competent authorities shall specify the objective data and criteria on the basis of which these measures have been taken with respect to its medicinal product. In such a case, the competent authorities shall also inform the marketing authorisation holder of all remedies available, including judicial, and of the time limits for applying for such remedies.

Chapter IV

Specific requirements

Article 12

Effectiveness of the time limits

1.   The time limits laid down in Articles 3, 4, 5 and 7 shall be construed as the period between the receipt of an application or additional information, as the case may be, and the effective entry into force of the corresponding decision. All expert evaluations and administrative steps necessary for taking the decision and bringing it into effect shall be carried out within the prescribed time limits.

1a.
     
  With respect to generic medicinal products, a certain period for submitting an application and a certain period for the effective entry into force of the corresponding decision shall, however, not be included in the time limits, provided that neither of those periods exceeds one calendar month each and that those periods are explicitly regulated by national legislation or administrative guidelines. [Am. 52]

1b.
     
  If a decision-making process involving negotiations between the marketing authorisation holder and the competent authority is required, the time limits laid down in Articles 3, 4, 5 and 7 shall be suspended from the time the competent authority communicates its proposals to the marketing authorisation holder until it receives the marketing authorisation holder's response to its proposals. [Am. 53]

Article 13

Additional proof of quality, safety, efficacy or bioequivalence

  Non-reassessment of essential marketing authorisation elements

1.
     In the framework of pricing and reimbursement decisions, Member States

  the competent authorities
  shall not re-assess the
  essential
  elements on which the marketing authorisation is based, including the

  such as
  quality, safety, efficacy or, bioequivalence of the medicinal product

  , biosimilarity or criteria for orphan designation
  .

1a.
     
  Paragraph 1 shall be without prejudice to the right of the competent authorities to request and have full access to data generated during the marketing authorisation process for the purpose of evaluation and health technology assessment, so that they can assess the relative efficacy as well as the short- and long-term effectiveness, where appropriate, of a medicinal product in the context of its inclusion in the scope of the public health insurance system.

1b.
     
  The competent authorities shall also be able to include or generate additional relevant data for the purpose of assessing medicinal products. [Am. 54]

Article 14

Non-interference of intellectual property rights

1.   Applications, decision-making procedures and decisions to regulate the prices of medicinal products in accordance with Article 3 or to determine their inclusion within the scope of public health insurance systems in accordance with Articles 7 and 9 shall be considered by Member States as administrative procedures which, as such, are independent from the enforcement of intellectual property rights.

2.   The protection of intellectual property rights shall not be a valid ground to refuse, suspend or revoke decisions relating to the price of a medicinal product or its inclusion within the public health insurance system.

3.   Paragraphs 1 and 2 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Chapter V

Transparency mechanisms

Article 15

Consultation of interested parties

Where a Member State intends to adopt or amend any
  legislative
  measure falling within the scope of this Directive, it shall give interested parties
  , including civil society organisations such as patient and consumer groups,
  the opportunity to comment on the draft measure within a reasonable period. The competent authorities shall publish the rules applicable to consultations. The results of consultations shall be made publicly available, with the exception of confidential information in accordance with Union and national legislation regarding business confidentiality. [Am. 55]

Article 15a

Transparency of decision-making bodies and prices

1.
     
  Member States shall ensure that the competent authorities controlling the prices of medicinal products or determining the coverage of medicinal products by public health insurance systems make publicly available a regularly updated list of the members of their decision-making bodies, together with their declarations of interest.

2.
     
  Paragraph 1 shall also apply to the administrative body referred to in Article 8(2).

3.
     
  The competent authorities shall publish in an appropriate publication and communicate to the Commission, at least once a year, a complete list of the medicinal products covered by their public health insurance systems and the prices which have been set during the relevant period. [Am. 56]

Article 16

Notification of draft national measures

1.   Where Member States intend to adopt or amend any measure falling within the scope of this Directive, they shall immediately communicate to the Commission the draft measure envisaged, together with the reasoning on which the measure is based.

2.   Where appropriate, Member States shall simultaneously communicate the texts of the basic legislative or regulatory provisions principally and directly concerned, if knowledge of such texts is necessary to assess the implications of the measure proposed.

3.   Member States shall communicate the draft measure referred to in paragraph 1 again if they make changes to the draft that have the effect of significantly altering its scope or substance, or shortening the timetable originally envisaged for implementation.

4.   The Commission may send its observations to the Member State which has communicated the draft measure within three months.

The observations of the Commission shall be taken into account as far as possible by the Member State concerned, in particular if the observations indicate that the draft measure may be incompatible with Union law.

5.   When the Member State concerned definitively adopts the draft measure, it shall communicate the final text to the Commission without delay. If observations have been made by the Commission in accordance with paragraph 4, this communication shall be accompanied by a report on the actions taken in response to the observations of the Commission.
  [Am. 57]

Article 17

Report on the implementation of the time limits

1.   By 31 January of ... (12), and by 31 January and 1 July of every year thereafter, Member States shall communicate to the Commission and publish in an appropriate publication a detailed report providing the following information: [Am. 58]

| (a) | the number of applications received in accordance with Articles 3, 4 and 7 during the preceding year; |
| --- | --- |

(a)

the number of applications received in accordance with Articles 3, 4 and 7 during the preceding year;

| (b) | the amount of time taken to issue a decision on each of the applications received in accordance with Articles 3, 4, and 7; |
| --- | --- |

(b)

the amount of time taken to issue a decision on each of the applications received in accordance with Articles 3, 4, and 7;

| (c) | an analysis of the main reasons for delays, if any, together with recommendations to bring decision-making processes into line with the time limits laid down in this Directive. |
| --- | --- |

(c)

an analysis of the main reasons for delays, if any, together with recommendations to bring decision-making processes into line with the time limits laid down in this Directive.

For the purposes of point (a) of the first subparagraph, a distinction shall be made between generic medicinal products subject to shorter time limits in accordance with Articles 3, 4 and 7 and other medicinal products.

For the purposes of point (b) of the first subparagraph, any suspension of the procedure to request additional information to the applicant shall be reported with a clear indication of the duration of the suspension and the detailed reasons for the suspension.

2.   The Commission shall publish every six months

  year
  a report on the information submitted by Member States according to paragraph 1. [Am. 59]

Chapter VI

Final provisions

Article 18

Transposition

1.   Member States shall adopt and publish, by ... (13) at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

They shall apply those provisions from ... (14)

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 19

Report on the implementation of this Directive

1.   Member States shall send a report to the Commission on the implementation of this Directive by ... (15) and every three years thereafter.

2.   By ... (16), the Commission shall submit a report to the European Parliament and the Council on the implementation of this Directive. The report may be accompanied by any appropriate proposals.

Article 20

Repeal

Directive 89/105/EEC is repealed from ... (17).

The effects of Article 10 of Directive 89/105/EEC shall be maintained.

References to the repealed Directive shall be construed as references to this Directive.

Article 21

Entry into force and application

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 22

Addressees

This Directive is addressed to the Member States.

Done at

For the European Parliament

The President

For the Council

The President

---

(1)  OJ C 299, 4.10.2012, p. 81.

1

(2)  Position of the European Parliament of 6 February 2013.

2

(3)  OJ L 40, 11.2.1989, p. 8.

3

(4)  OJ L 311, 28.11.2001, p. 67.

4

(5)  

  OJ C 299, 4.10.2012, p. 81.

5

OJ C 299, 4.10.2012, p. 81.

(6)  

  OJ L 88, 4.4.2011, p. 45.

6

OJ L 88, 4.4.2011, p. 45.

(7)  OJ C 369, 17.12.2011, p. 14.

7

(8)  Council Directive 89/665/EEC of 21 December 1989 on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contracts (OJ L 395, 30.12.1989, p. 33).

8

(9)  Council Directive 92/13/EEC of 25 February 1992 coordinating the laws, regulations and administrative provisions relating to the application of Community rules on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors (OJ L 76, 23.3.1992, p. 14).

9

(10)  Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (OJ L 134, 30.4.2004, p. 114).

10

(11)  

  OJ L 136, 30.4.2004, p. 1.

11

OJ L 136, 30.4.2004, p. 1.

(12)  The year following the date referred to in the first subparagraph of Article 18(1).

12

(13)  Last day of the 12th month following publication of this Directive in the Official journal of the European Union.

13

Official journal of the European Union

(14)  The day after the date set out in the first subparagraph.

14

(15)  Two years after the date referred to in the second subparagraph of Article 18(1).

15

(16)  Three years after the date referred to in the second subparagraph of Article 18(1).

16

(17)  The date set out in the second subparagraph of Article 18(1).

17

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